Cleared Traditional

IMMULITE/IMMULITE? 1000 Cortisol

K203270 · Siemens Healthcare Diagnostics Products, Ltd. · Chemistry

Jan 2021

Decision

71d

Days

Class 2

Risk

About This 510(k) Submission

K203270 is an FDA 510(k) clearance for the IMMULITE/IMMULITE? 1000 Cortisol, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Siemens Healthcare Diagnostics Products, Ltd. (Caemarfon, GB). The FDA issued a Cleared decision on January 15, 2021, 71 days after receiving the submission on November 5, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K203270 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2020
Decision Date	January 15, 2021
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF